Good Clinical Practice (GCP) and Multi-Regional Clinical Trials (MRCT) Training
Focus Area: Capacity Building
Consistent with the goals of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH), regulatory authorities worldwide wish to ensure that drugs, biologics and devices are developed by processes that uphold the highest ethical standards and scientific principles.
These processes depend upon consensus understanding of the principles underlying drug development, clinical and research practices, regulatory review of submitted data, regulatory inspections and post-approval monitoring. Further, evolving technologies, capacities, and study design require periodic review and adaptation of the ICH guidelines. Harmonized technical guidelines to which global regulators commit can speed the process for efficient and effective registration, approval, and monitoring. A shared interpretation of these guidelines is essential to a cooperative and global effort to promote and protect public health.
ICH selected the MRCT Center to conduct a pilot training and has subsequently endorsed the MRCT Center as an ICH Training Partner. Likewise, the Asia-Pacific Economic Cooperation (APEC) endorsed the MRCT Center as a Pilot Center of Excellence (CoE). Consequently, the MRCT Center hosted two pilot trainings with a focus on the global standards published by the ICH that address best practices for the design, conduce, and oversight of clinical trials. The goals of these multi-day training conferences were to build local regulatory capacity, particularly in emerging economies, in good clinical practices (GCP, ICH E6(R2)) and to facilitate review and oversight of multi-regional clinical trails (MRCTs, ICH-E17). The trainings were in-person, interactive, and case-based, facilitated by senior professionals from the European Medicines Agency (EMA), US Food and Drug Administration (FDA) , Health Canada, Health Products Regulatory Authority (HPRA) Ireland, Pharmaceuticals and Medical Devices Agency (PMDA, Japan), industry partners and MRCT Center Leadership.
Following these successful pilot trainings, the MRCT Center has been approached to lead additional in-country trainings, to develop online training, and to submit an application to become an APEC Center of Excellence.
Current status: Active project
Impact: Improved regulatory capacity to provide a unified standard for conducting and oversight of clinical trials.
- Describe the standards of Good Clinical Practice (GCP) and key considerations in Multi-Regional Clinical Trials (MRCTs) design as set out in ICH E6(R2) and ICH E17 guidance, respectively.
- Describe models of implementation of the changes in the ICH E6(R2) addendum and ICH E17 guidance to increase the acceptability of MRCT data by multiple regulatory authorities.
- Demonstrate practical approaches to fulfilling the requirements of ICH E6(R2) and ICH E17 consistent with ICH standards.
- Describe and demonstrate best practices to assess clinical trial regulatory submissions, including study design, data packages, essential documents, reports, and filings for alignment with ICH GCP and MRCT.
- Define inspection methodologies to assess clinical trial conduct for alignment with ICH GCP and MRCT standards, including review of corrective actions.
- February 2017: APEC endorsed MRCT Center as Pilot Center of Excellence for Multi-Regional Clinical Trials (MRCTs) and Good Clinical Practice (GCP)
- April 2017: ICH endorsed MRCT Center to conduct ICH GCP pilot training
- May 2017: First planning committee meeting for ICH E6(R2) pilot training
- June 2017: Application process opened for ICH GCP pilot training
- June 2017: First planning committee meeting for APEC Pilot CoE training
- October 2017: ICH GCP Pilot Training at Harvard Faculty Club
- November 2017: MRCT Center endorsed as ICH Training Partner by the ICH Management Committee
- April 2018: Conducted APEC Pilot CoE training on MRCT and GCP at Harvard Faculty Club
- October 2018: MRCT Center designated as APEC LSIF (Life Sciences Innovation Forum) RHSC (Regulatory Harmonization Steering Committee) Training Center of Excellence for Regulatory Science in the area of Multi-regional Clinical Trials and Good Clinical Practice Inspection
Program Managers: Carmen Aldinger, Sylvia Baedorf Kassis